Building, growing, and maintaining a molecular oncology testing laboratory involves extensive basic and applied knowledge in oncology, anatomic pathology, and laboratory medicine, and a diverse skill set in technical operations, test interpretation, and financial and regulatory topics. Clinical and Laboratory Standards Institute MM26—Cancer Molecular Testing: Principles of Oncology Test Interpretation, Laboratory and Assay Design, and Clinical Consultation reviews the current key concepts in molecular oncology, indications for testing, and laboratory and test design. It is intended to provide management personnel, particularly the laboratory director as well as technical and medical directors and pathologists, with practical and actionable information for strategic planning and daily laboratory operations. CLSI MM26 includes guidance focused on providing molecular oncology laboratory consultations to clinical providers and other stakeholders, including through molecular tumor boards. Emerging areas of testing such as liquid biopsy and identifying germline variants in cancer panels are also included. The infrastructure and best practices for data sharing of cancer genomic results and keeping the laboratory up-to-date with technologies and test development in the rapidly evolving areas of cancer genomics, such as single-cell sequencing and digital spatial profiling, are also discussed.

CLSI MM26 emphasizes the essential role of the laboratory director (LD) and/or other applicable personnel in the molecular oncology laboratory in: 

• Launching well-designed and well-validated genomic assays and/or monitoring external providers for seamless delivery of testing services 

• Engaging effectively with medical care personnel to accurately describe and convey the appropriate clinical indications for requesting genetic analysis for malignancies 

• Ensuring accurate interpretation(s) of genetic test findings and the implications of the test results for establishing the patient’s diagnosis, prognosis, and treatment selection; monitoring patient’s response to therapy; and detecting cancer progression 

• Ensuring awareness of the limitations of test findings, such as additional genes or variants that might not have been included in the analyses but can also contribute to the patient's condition 

• Sustaining laboratory quality, innovative testing, and laboratory programs that keep pace with technologic developments and the clinical needs of the laboratory’s stakeholders CLSI MM26 does not include detailed descriptions of molecular testing methods or analytical techniques that are covered in CLSI MM01, MM07, MM09, MM17, and MM21. Other CLSI documents provide comprehensive overviews of hematopathology (CLSI MM06), solid tumor diagnostics (CLSI MM23), and new molecular laboratory start-up (CLSI MM19). 

The target audience includes: 

• Directors and supervisors employed by laboratories that perform cancer molecular testing 

• Pathologists, scientists, and genetic counselors who are involved in selecting cancer tests and interpreting results 

• LDs who are involved in developing curriculum for training purposes 

• Personnel who are involved in developing cancer research protocols 

• Field application specialists who work in the cancer diagnostics industry